药品名称GRIS-PEG
申请号050475产品号001
活性成分GRISEOFULVIN, ULTRAMICROSIZE市场状态处方药
剂型或给药途径TABLET;ORAL规格125MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT PHARMACEUTICALS INTERNATIONAL INC
化学类型New formulation or new manufacturer审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
050475057APLabel2016/04/20下载
050475057APLetter2016/04/22下载
050475054APLabel2010/10/19下载
050475054APLetter2010/10/25下载
050475053APLabel2007/02/02下载
050475053APLetter2007/02/02下载
050475046APLabel2003/03/28下载
050475046APLetter2003/04/14下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
050475058AP2016/09/01Manufacturing Change or Addition
050475057AP2016/04/19Labeling Revision
050475056AP2013/05/08Manufacturing Change or Addition
050475054AP2010/10/19Labeling Revision
050475053AP2007/01/24Labeling Revision
050475051AP2002/08/01Control Supplement
050475050AP2002/06/03Control Supplement
050475049AP2001/07/02Manufacturing Change or Addition
050475048AP2000/12/06Manufacturing Change or Addition
050475047AP1998/04/16Control Supplement
050475046AP2003/03/26Labeling Revision
050475045AP1997/04/07Control Supplement
050475044AP1982/12/21Expiration Date Change
050475043AP1982/12/21Formulation Revision
050475042AP1982/06/28Labeling Revision
050475041AP1982/02/05Control Supplement
050475037AP1981/07/06Expiration Date Change
050475034AP1981/03/05Expiration Date Change
050475033AP1981/03/02Package Change
050475032AP1980/08/13Labeling Revision
050475031AP1980/11/21Labeling Revision
050475029AP1980/01/04Control Supplement
050475028AP1980/01/04Package Change
050475027AP1980/01/21Expiration Date Change
050475025AP1979/04/10Formulation Revision
050475024AP1980/11/21Labeling Revision
050475022AP1978/01/17Control Supplement
050475021AP1977/07/26Labeling Revision
050475020AP1977/04/20Manufacturing Change or Addition
050475019AP1976/12/08Manufacturing Change or Addition
050475018AP1976/11/18Labeling Revision
050475017AP1976/11/18Control Supplement
050475016AP1976/10/01Package Change
050475015AP1976/08/04Labeling Revision
050475013AP1976/09/16Expiration Date Change
050475012AP1976/04/01Package Change
050475011AP1976/01/16Control Supplement
050475010AP1975/06/20Control Supplement
050475009AP1975/07/16Formulation Revision
050475008AP1988/06/20Expiration Date Change
050475006AP1986/09/16Manufacturing Change or Addition
050475004AP1984/10/24Manufacturing Change or Addition
050475003AP1984/04/24Manufacturing Change or Addition
050475002AP1983/02/17Formulation Revision
050475001AP1983/01/26Manufacturing Change or Addition
050475000AP1975/04/16Approval